The collaboration aims to leverage Gracell's extensive experience in immune cell therapy in synergy with
CLDN18.2 is a tumor-specific marker that is overexpressed in a variety of tumor tissues, including in gastric or gastroesophageal junction cancers, pancreatic cancers and esophageal cancers, but rarely expressed in normal human tissues. This feature supports the therapeutic potential of CLDN18.2 as a key target for immune cell therapies. In particular, gastric cancer (around 70% CLDN18.2 expression) is among the most frequently diagnosed malignancies worldwide and the second leading cause of cancer-related death. An estimated 1,033,701 new cases and 782,685 deaths occurred in 2018, representing a highly unmet medical need in treating gastric cancer.
"Gracell has been making significant progress in developing innovative CAR-T therapies for solid tumors as well as hematological malignancies," Dr.
"Gracell has been optimizing its proprietary Enhanced CAR technology to improve CAR-T cell persistence and efficacy in solid tumors. The preliminary clinical investigator-initiated trial data of our first generation Enhanced CAR-T for solid tumors has shown tolerability and preliminary efficacy. These initial results have been accepted to be published soon in Cellular & Molecular Immunology," said Dr.
Under the terms of the agreement,
CLDN18.2, a small transmembrane protein with four transmembrane domains and two extracellular loops, is overexpressed in a significant proportion of gastric cancers and esophageal adenocarcinomas. The restricted expression makes it a promising target for the treatment of gastric or gastroesophageal junction cancers, pancreatic cancers, etc. Overall, CLDN18.2 is prevalently expressed in the cancer tissues of approximately 70% of gastric cancer patients and approximately 60% of pancreatic cancer patients. CLDN18.2-specific antibodies developed to target CLDN18.2 have exhibited anti-tumor activity in preclinical studies.
About Enhanced CAR
Enhanced CAR is Gracell's proprietary technology that further strengthens the functionality of CAR-T cells, for example by overcoming the immunosuppressive tumor micro-environment (TME) and/or increasing cytokine signaling. Gracell utilizes gene editing technologies to edit some check point inhibitor(s) or/and cytokine(s) or cytokine receptor(s) on CAR-T cells to release potential suppression from tumor cells and other suppressive immune cells in tumor tissue to enhance CAR-T cells' functionality. Our second generation Enhanced CAR technology can be implemented to many other targets in several types of solid tumors.
Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn.
FutureGen Biopharm ("
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Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the
 Clinical Implications of Claudin18.2 Expression in Patients With Gastric Cancer
 Hsu A, Chudasama R, Almhanna K, Raufi A. Targeted therapies for gastroesophageal cancers. Ann. Transl. Med. (2020) 8:1104. doi: 10.21037/atm-20-3265
 The full-length Claudin 18.2 to accelerate antibody drug development
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